Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason

Surgical Port Site Hernia Clinical Trial

Official title:

Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374189
• Other study ID #: EZVSCT
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: February 2019
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Description:

Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 24, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients with laparoscopic ports over 10mm

Exclusion Criteria:

• Patients with laparoscopic ports under 10mm

• Patients who refused the study

• Patients who received concurrent surgery for other reason

Related Conditions & MeSH terms

• Surgical Port Site Hernia

Intervention

Device:
• EZ close
EZ close used.
• Carter Thomason
Carter Thomason used.

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device. J Endourol. 2014 Jul;28(7):814-8. doi: 10.1089/end.2014.0069. Epub 2014 Apr 23. — View Citation

Shetty A, Adiyat KT. Comparison between hand suture and Carter-Thomason needle closure of port sites in laparoscopy. Urol J. 2014 Sep 2;11(4):1768-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Taken to Complete Closure	The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.	At the time of surgery
Secondary	Number of Participants With Visceral Organ Injury	Any inadvertent injury to organs or bleeding during procedure.	At the time of surgery
Secondary	Number of Participants With Need for Additional Instrument	Need for additional instrument during procedure	At the time of surgery
Secondary	Number of Participants With Port-site Hernia	Herniation of bowel segments through port-site	3 days post-op and within one months of surgery
Secondary	Number of Participants With Port-site Infection	Redness, purulent discharge, tenderness at port-site	3 days post-op and within one months of surgery
Secondary	Number of Participants With Ascitic Fluid Leakage	Non-infective fluid leakage	3 days post-op and within one months of surgery
Secondary	Number of Participants With Wound Dehiscence	Wound dehiscence that required further treatment	3 days post-op and within one months of surgery